SBIA, in collaboration with the Drug Registration and Listing Branch (DRLB) in the Office of Compliance (OC), hosted its annual Electronic Drug Registration and Listing (eDRLS) Annual Conference 2024. This year’s event included an overview on registration and listing regulatory requirements and compliance framework, as well as demos and case studies for an interactive learning experience. Additionally, faculty discussed OTC drug listing requirements and its relation to the OTC Monograph Drug User Fee Program (OMUFA) assessment.

Timestamps

00:51 – Keynote

12:06 – CDER Direct Establishment Registration Demo

43:04 – Establishment Registration Highlights

54:47 – Complying with Establishment Registration Requirements

01:07:48 – CDER Direct Labeler Code Request Demo

01:26:28 – Labeler Code Request Highlights

01:35:42 – Complying with Labeler Code Request Requirements

01:44:36 – Q&A Panel

Speakers | Panelists:

Matthew Lash, JD
Deputy Director
Office of Compliance
Center for Drug Evaluation and Research (CDER) | FDA

Regie Samuel
Technical Information Specialist
Drug Registration and Listing Branch (DRLB)
Division of Labeling, Registration, and Unapproved Drugs (DLRUD)
Office of Unapproved Drugs & Labeling Compliance (OUDLC)
CDER | FDA

Jose Cabrera
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA

Tasneem Hussain, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA

Puii Huber
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA

Laurie Simonds, GWCPM
Technical Information Specialist
DRLB | DLRUD | OUDLC | CDER | FDA

Vikas Arora, PharmD
Consumer Safety Officer
DRLB | DLRUD | OUDLC | CDER | FDA

Learn more at: [ Ссылка ]

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FDA CDER’s Small Business and Industry Assistance (SBIA) educates and provides assistance in understanding the regulatory aspects of human drug products & clinical research.

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